CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 46 enrolled
Drug / intervention
Ketamine +1 moredrug
Likely dose
Ketamine 10 mcg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02424591
NCT02424591Phase 4Completed

A Prospective, Randomized, Single Blinded Comparison of Intraoperative Ketamine Infusion Versus Placebo in Patients Having Spinal Fusion

NYU Langone Health·interventional·Posted Apr 23, 2015·Updated Jun 14, 2017

In Brief

A Phase 4 clinical trial evaluating Ketamine and Placebo for Postoperative Pain. Completed, enrolled 46 participants across 1 site.

Detailed Summary

Postoperative pain is severe after major spine surgery. Opioids such as morphine and hydromorphone are routinely used for postoperative pain control. These drugs have significant side effects, most importantly respiratory depression, nausea, constipation and tolerance. Moreover, many spine surgery patients have used opioid pain medication for back pain long term, leading to pre-surgical opioid tolerance and increased postoperative pain. This has led to a search for adjuvant medications to reduce the use of opioids and reduce opioid mediated side effects and tolerance. Ketamine is an intravenous anesthetic with analgesic properties in subanesthetic doses. Ketamine is a noncompetitive antagonist of N-methyl-D-aspartate (NMDA) receptors. NMDA receptors are involved in central pain sensitization via wind-up phenomenon and altered pain memory, a process which can be blocked by ketamine. NMDA receptor antagonists may prevent the development of tolerance to opioids and hyperalgesia. Ketamine has been safely used to decrease pain in numerous studies. Ketamine can also act as an antidepressant with hours of administration. Ketamine has rapid brain uptake and subsequent re-distribution with a distribution half-life of 10-15 minutes and an elimination half-life of 2 hours. Ketamine does not cause respiratory depression.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedApr 23, 2015
Enrollment StartAug 1, 2014
Primary CompletionJan 1, 2016
Study CompletionOct 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 11.2 years ago

Interventions

Ketaminedrug

Infusion at a rate of 10 mcg/kg/min

Placeboother

Placebo IV